SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
FDA 510(k) clearance K052485 · decided 2006-01-17
Clearance details
- K-number
- K052485
- Device name
- SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
- Applicant
- Midi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-09
- Decision date
- 2006-01-17
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- NWZ
- Device class
- 2
- Regulation number
- 866.3045
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.